The Basel-based firm has filed infringement proceedings and is seeking an injunction against Biocon at Delhi’s High Court to try to stop the Indian company launching a generic version of vildagliptin (or Galvus).

In response to a mail from Business Today on the reasons why it had chosen to file a patent infringement suit against Biocon, a Novartis spokesperson in a written response says: “On March 27, 2014, Novartis filed infringement proceedings seeking an injunction against Biocon Ltd at the Delhi High Court for infringement of the Indian basic compound patent (expiry 2019) covering and claiming the novel molecule Vildagliptin. During the hearing which took place on March 28, 2014, the court recorded a statement whereby Biocon will not manufacture, sell or export Vildagliptin for commercial purposes till the next court hearing.”

Doctors say this is one of the drugs usually given as an add-on to an existing therapy to manage diabetes. It is expensive, costing around Rs 20 per tablet and typically a patient will need to incur an expense of Rs 40 per day as against Rs 3 to Rs 5 for the usual diabetes drugs.

Therefore, there is a good reason why an innovator would want to retain its market and a generic player equally keen to enter this space.

However, Biocon’s Chairman and Managing Director Kiran Mazumdar-Shaw told Business Today that the pharmaceutical major “has not been issued any injunction on Vildagliptin; nor has Biocon launched the product in India. There is no impact on our immediate plans for this product.”

In a statement issued earlier, a company spokesperson had said: “Biocon has a reputation for respecting all valid IPs and intends to operate within the parameters of applicable IP laws in India and elsewhere.”

The suit is a proactive step being taken by Novartis to ensure there is no drug launched when its patent is still in force. And, as far as Biocon is concerned, while it does not have this drug in the market, it may work on the therapy and perhaps launch the drug once the Novartis patent expires.

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